Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)

Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.

Time frame: Baseline, Week 8

Percentage of Participants Achieving Blood Pressure Control at Endpoint

Blood pressure control is defined as having as a msDBP \< 90 mmHg and a msSBP \< 140 mmHg.

Time frame: 8 weeks

Percentage of Participants Achieving a Successful Response Rate

The response rate was defined as percentage of participants who achieved msDBP \< 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.

Time frame: 8 weeks